The Dossier Management application addresses the generation of form FDA-356h_R9 for new drug approval. An NDA application is created which generates form FDA-356h_R9 with additional contents that are selected during the inputs for the application and bundled all together to send over to the FDA as a product for new drug approval under FDA law.

The overall process assists applicants in generating the forms and helps to compile and track the dossier.

The auto-generation of forms based on  user inputs improves the overall cycle time and provides better accuracy by providing validation and  eliminating the chances of incorrect data entry.  It also allows form filing to be less of a hassle and more user friendly. Only the authorized group can approve or review the particular application providing even more robustness through the complete process. These workflows provide real-time status updates  in a management dashboard that focuses on overall aging thus giving a clear view into the current state at any time.

Key Application Highlights:

  • Helps to compile dossier and track the dossier status.
  • Easy-to-use templates for user completion.
  • Generates forms based on the received inputs.
  • Easy to manage and track NDA dossier status.
  • Comprehensive view for users to access NDA information and documents.
  • Allows creation of a dossier table and the ability to manage the dossier.
  • Generation of reports for all NDA requests with filters.
  • Live view on the status and progress of the application.


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